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Chemotherapy

Neoadjuvant therapy for Breast Cancer (NeoADAPT Trial)

Phase 2

Recruiting

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

NeoADAPT Trial Summary

This trial will treat patients with stage 2 and 3 triple negative breast cancer with a combination of drugs before surgery. Patients will receive 4 cycles of treatment and undergo PET scans and MRI to monitor

Who is the study for?

This trial is for individuals with stage 2 or 3 triple negative breast cancer. Participants will undergo specific chemotherapy and immunotherapy treatments, followed by imaging tests like PET scans and MRI to monitor response. Those showing complete clinical response go straight to surgery; others receive additional chemo before surgery.Check my eligibility

What is being tested?

The study tests a combination of neoadjuvant therapies (paclitaxel, carboplatin, pembrolizumab) in patients with TNBC, using PET scans for early treatment adaptation. It explores whether changing therapy based on PET scan results can improve outcomes before surgery.See study design

What are the potential side effects?

Potential side effects include nausea, hair loss, fatigue from chemotherapy drugs like doxorubicin and paclitaxel; low blood counts from carboplatin; skin reactions from pembrolizumab; hand-foot syndrome from capecitabine.

NeoADAPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My breast cancer is stage II-III, with low ER and PR levels.

NeoADAPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

SULmax in relation to pCR

Secondary outcome measures

Circulating tumor deoxyribonucleic acid (ctDNA) clearance

Pathologic complete response (pCR)

Other outcome measures

Change in microbiome

Clinical complete response (cCR) and pathologic complete response (pCR)

Diagnostic accuracy of percent and absolute change between baseline and C1D15 measurements

+1 more

NeoADAPT Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant therapyExperimental Treatment7 Interventions

4 cycles of paclitaxel/carboplatin/pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~3420

Cyclophosphamide

1995

Completed Phase 3

~3770

Doxorubicin

2012

Completed Phase 3

~7940

Carboplatin

2014

Completed Phase 3

~6670

Pembrolizumab

2017

Completed Phase 2

~2010

Paclitaxel

2011

Completed Phase 4

~5380

Olaparib

2007

Completed Phase 4

~2140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

559 Previous Clinical Trials

32,969 Total Patients Enrolled

44 Trials studying Breast Cancer

4,978 Patients Enrolled for Breast Cancer

Cesar A Santa-Maria, MDStudy ChairJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of Neoadjuvant therapy in individuals?

"As this is a Phase 2 trial, the safety of Neoadjuvant therapy has been rated as a 2 by our team at Power. This indicates that there exists some information supporting its safety profile but no evidence yet for efficacy."

Answered by AI

Are there any available slots for patients to participate in this clinical trial?

"As per the details available on clinicaltrials.gov, recruitment for this particular research endeavor is currently closed. The trial was initially listed on 2/1/2024 and last revised on 2/5/2024. Despite its closure, there are approximately 2377 alternative clinical trials actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

2024. "PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06245889.

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